Cleared Special

K093616 - V. MUELLER CAMERA CONTROLLER WITH STORA...

K093616 is an FDA 510(k) clearance for V. MUELLER CAMERA CONTROLLER WITH STORA..., manufactured by Carefusion 2200. The device is a Class 2 Gastroenterology & Urology device with product code OCV cleared through the Special 510(k) pathway after a 34-day FDA review.

K093616 · Carefusion 2200 · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
34d
Days
Class 2
Risk

K093616 is an FDA 510(k) clearance for the V. MUELLER CAMERA CONTROLLER WITH STORAGE CART. Classified as Endoscope Holder (product code OCV), Class II - Special Controls.

Submitted by Carefusion 2200 (Waukegan, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Carefusion 2200 devices

FDA 510(k) Submission Details - K093616

510(k) Number K093616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2009
Decision Date December 23, 2009
Days to Decision 34 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 130d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

OCV Device Classification - Class 2, Special Controls

Product Code OCV Endoscope Holder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold Endoscope In A Desired Position During Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCV Endoscope Holder

Devices cleared under the same product code (OCV) and FDA review panel - the closest regulatory comparables to K093616.
KARL STORZ Holders
K240506 · KARL STORZ Endoscopy-America, Inc. · Oct 2024
ENDOFIX EXO
K232405 · Aktormed GmbH · Apr 2024
WalterLorenz Surgical Assist Arm Scope Holder
K190576 · Biomet Microfixation · Jun 2019
KSEA ENDOSCOPE HOLDER
K990334 · KARL STORZ Endoscopy-America, Inc. · Mar 1999
SH-1 SURGICAL HOLDER FOR TELESCOPE
K960068 · Olympus America, Inc. · May 1997